MedPath

KINKAN

Approved
Approval ID

f2c0f3e1-792b-4798-bf6d-acd1bbefa261

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

KINKANDO CO., LTD .

DUNS: 694329470

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ammonia, camphor (natural), menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51027-0007
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
ammonia, camphor (natural), menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 10, 2025
FDA Product Classification

INGREDIENTS (4)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAActive
Quantity: 1.1 g in 50 mL
Code: 5138Q19F1X
Classification: ACTIB
CAMPHOR (NATURAL)Active
Quantity: 1.55 g in 50 mL
Code: N20HL7Q941
Classification: ACTIB
MENTHOLActive
Quantity: 3 g in 50 mL
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/6/2025

Principal Display Panel - 50 mL Bottle Label

NDC 51027-0007-1

KINKAN

PAIN
RELIEVING
LINIMENT

MANUFACTURED BY
**KINKANDO CO., LTD.**350-2 KODAMACHOKYOEI,
HONJO-SHI, SAITAMA 367-0206,
JAPAN

DISTRIBUTED BY
PMAI21112 Figueroa Street unit B

Carson, CA 90745

1.7 FL OZ (50mL)

Principal Display Panel - 50 mL Bottle Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/9/2019

Uses

Temporary relief of minor aches and pains of muscles and joints due to

  • simple backache
  • arthritic
  • strains
  • bruises
  • sprains

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/6/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/9/2019

Active ingredients

Ammonia 2.3%

Camphor 3.1%

Menthol 6.0%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/9/2019

Purpose

External Analgesic

External Analgesic

External Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 10/9/2019

Warnings

For external use only

Flammable keep away from fire or flame

Do not use on

  • wounds
  • damaged skin

When using this product

  • avoid contact with the eyes and mouth
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact.“a Poison Control Center right away.”

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/9/2019

Directions

Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do not use, consult a doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 10/9/2019

Other Information

  • Store at room temperature under 86°F (30°C)
  • Flammable. keep away from fire or flame

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/9/2019

Inactive ingredients

Geraniol-denatured Alcohol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/9/2019

Questions and comments

Call 1-310-661-7260 Mon.-Fri. (2p.m. - 3p.m. PST)

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KINKAN - FDA Drug Approval Details